Lower Urinary Tract SymptomsNCT03451175
Reproductibility of Cystometry in Multiple Sclerosis Patient
An observational study of Lower Urinary Tract Symptoms and Cystometry, run by Pierre and Marie Curie University at 1 site in France.
Trial summary
This study evaluates the reproductibility (quantitative and qualitative) of cystometry in mutiple sclerosis patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lower Urinary Tract Symptoms, Cystometry, Multiple Sclerosis
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2017to 1 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multiple sclerosis patients with overactive detrusor consulting in neurobiology center.
Who may be able to join
- All patient with Multiple Sclerosis referred for urinary disorders,
- coming for a urodynamic evaluation with multiple cystometries during the study - detrusor overactivity for a filling of 300 ml or less on the first cystometry.
Who cannot join
- significate difference between the filling volume during the study and the volume truly of water truly collected after catheterization,
- an urinary tract infection,
- an other acute disease.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the reproductibility (quantitative and qualitative) of cystometry in mutiple sclerosis patients.
Read the detailed description
Some studies have evaluated the reproductibility of urodynamics in women with stress incontinence, and demonstrated a poor reproductibility of urodynamic parameters for a part of the studies and a good reproductibility for the others. There is only three studies investigating the reproductibility of repeated cystometries in patients with overactive detrusor and neurogenic lower tract dysfunction. The most common etiology in these studies is spinal cord injury. Only one article includes MS patients with lower urinary tract symptoms (22 patients among 226 with other etiologies).
The aim of this study was to assess the short term reproductibility in multiple sclerosis patients with qualitative and quantitative urodynamic data.
The authors conducted a prospective analysis in our Neuro-urology department of a University Hospital . All patient with Multiple Sclerosis referred for urinary disorders, coming for a urodynamic evaluation with multiple cystometries during the study were included if they had a detrusor overactivity for a filling of 300 ml or less on the first cystometry. The main exclusion criteria were a significate difference between the filling volume during the study and the volume truly of water truly collected after catheterization, an urinary tract infection, or an other acute disease.The investigators performed a first cystometry and looked for a detrusor overactivity, if the investigators discovered an involuntary detrusor contraction for a filling of 300 ml or less, the authors realized two others cystometries (filling rate of 50 mL/min) after informed consent. The volume and pressure at which the first and the maximal involuntary detrusor contraction, MCC were documented.
- Conditions
- Lower Urinary Tract Symptoms, Cystometry, Multiple Sclerosis, Overactive Bladder, Overactive Detrusor
- Keywords
- Overactive Detrusor, Multiple Sclerosis, Reproductibility, Cystometry
- Medical subject headings
- Lower Urinary Tract Symptoms, Multiple Sclerosis, Urinary Bladder, Overactive
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproductibility of urodynamic Capacity Cystometric Maximum (CCM)
Reproductibility of Capacity cystometric maximum (in ml) in the three cystometries evaluated using an intra class correlation
Measured: 1 Day : during the urodynamic assessment
Reproductibility of urodynamic : Pressure maximum
Reproductibility of Pressure Maximum (in cmH2O) in the three cystometries evaluated using an intra class correlation
Measured: 1 Day : during the urodynamic assessment
Reproductibility of urodynamic : Pressure of the first involuntary detrusor contraction (IDC)
Reproductibility of pressure of the first involuntary detrusor contraction (in cmH2O) in the three cystometries evaluated using an intra class correlation
Measured: 1 Day : during the urodynamic assessment
Reproductibility of urodynamic : volume of filling for the first IDC
Reproductibility of volume of filling for the first involuntary detrusor contraction (in cmH2O) in the three cystometries evaluated using an intra class correlation
Measured: 1 Day : during the urodynamic assessment
Secondary outcomes (1)
Comparaison of urodynamic parameters between naive treatment patient and non naive treatment patients
Comparaison urodynamic parameters (CCM, Maximum pressure, volume filling of the first IDC, pressure of the first IDC) using a T student test
Measured: 1 Day : during the urodynamic assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start2 Jul 2017
- Primary completion1 Nov 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre and Marie Curie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gérard Amarenco, Pierre and Marie Curie University
- Investigators
- Gerard AMARENCO, PhD, Principal investigator, GREEN GRC-01, Neuro-urology, hôpital Tenon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451175
- Sponsor's protocol ID
- P. GREEN 0001
- Status last verified
- Feb 2018
- First submitted
- 11 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductibility of Cystometry in Multiple Sclerosis Patient
- ClinicalTrials.gov ID
- NCT03451175
- Acronym / sponsor ID
- P. GREEN 0001
- Conditions
- Lower Urinary Tract Symptoms, Cystometry, Multiple Sclerosis, Overactive Bladder, Overactive Detrusor
- Keywords
- Overactive Detrusor, Multiple Sclerosis, Reproductibility, Cystometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Pierre and Marie Curie UniversityUniversity, hospital or other
- Study start
- 2 Jul 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the reproductibility (quantitative and qualitative) of cystometry in mutiple sclerosis patients.
Detailed description
Some studies have evaluated the reproductibility of urodynamics in women with stress incontinence, and demonstrated a poor reproductibility of urodynamic parameters for a part of the studies and a good reproductibility for the others. There is only three studies investigating the reproductibility of repeated cystometries in patients with overactive detrusor and neurogenic lower tract dysfunction. The most common etiology in these studies is spinal cord injury. Only one article includes MS patients with lower urinary tract symptoms (22 patients among 226 with other etiologies).
The aim of this study was to assess the short term reproductibility in multiple sclerosis patients with qualitative and quantitative urodynamic data.
The authors conducted a prospective analysis in our Neuro-urology department of a University Hospital . All patient with Multiple Sclerosis referred for urinary disorders, coming for a urodynamic evaluation with multiple cystometries during the study were included if they had a detrusor overactivity for a filling of 300 ml or less on the first cystometry. The main exclusion criteria were a significate difference between the filling volume during the study and the volume truly of water truly collected after catheterization, an urinary tract infection, or an other acute disease.The investigators performed a first cystometry and looked for a detrusor overactivity, if the investigators discovered an involuntary detrusor contraction for a filling of 300 ml or less, the authors realized two others cystometries (filling rate of 50 mL/min) after informed consent. The volume and pressure at which the first and the maximal involuntary detrusor contraction, MCC were documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple sclerosis patients with overactive detrusor consulting in neurobiology center.
Key inclusion criteria (2 listed)
- All patient with Multiple Sclerosis referred for urinary disorders,
- coming for a urodynamic evaluation with multiple cystometries during the study - detrusor overactivity for a filling of 300 ml or less on the first cystometry.
Key exclusion criteria (3 listed)
- significate difference between the filling volume during the study and the volume truly of water truly collected after catheterization,
- an urinary tract infection,
- an other acute disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reproductibility of urodynamic Capacity Cystometric Maximum (CCM)
Time frame: 1 Day : during the urodynamic assessment
Reproductibility of Capacity cystometric maximum (in ml) in the three cystometries evaluated using an intra class correlation
Reproductibility of urodynamic : Pressure maximum
Time frame: 1 Day : during the urodynamic assessment
Reproductibility of Pressure Maximum (in cmH2O) in the three cystometries evaluated using an intra class correlation
Reproductibility of urodynamic : Pressure of the first involuntary detrusor contraction (IDC)
Time frame: 1 Day : during the urodynamic assessment
Reproductibility of pressure of the first involuntary detrusor contraction (in cmH2O) in the three cystometries evaluated using an intra class correlation
Reproductibility of urodynamic : volume of filling for the first IDC
Time frame: 1 Day : during the urodynamic assessment
Reproductibility of volume of filling for the first involuntary detrusor contraction (in cmH2O) in the three cystometries evaluated using an intra class correlation
1 secondary outcome
Comparaison of urodynamic parameters between naive treatment patient and non naive treatment patients
Time frame: 1 Day : during the urodynamic assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard AMARENCO, PhD principal investigator
GREEN GRC-01, Neuro-urology, hôpital Tenon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms and Cystometry, run by Pierre and Marie Curie University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproductibility of urodynamic Capacity Cystometric Maximum (CCM) (time frame: 1 Day : during the urodynamic assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.